FDA Refuses to File Harmony’s Supplemental NDA of Pitolisant in Idiopathic Hypersomnia

Marketed as Wakix, the treatment is currently approved in the United States for excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy and for EDS in pediatric patients aged 6 and older.:

Source: Neurology Read More

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FDA Refuses to File Harmony’s Supplemental NDA of Pitolisant in Idiopathic Hypersomnia

Previous PostManaging NMOSD Disease Progression Through Healthy Habits and Holistic Care: Tammy Smith, MD, PhD

Next PostFDA Accepts NDA for Vatiquinone as Potential Treatment for Friedreich Ataxia

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